1. Scope of the Invention
The present invention relates to tissue localization in a living subject.
2. Related Prior Art
Typically, it is necessary to determine if a lesion is present within breast tissue of a living subject prior to treating it. To locate a lesion within the breast, tissue is imaged with a reference frame having reference markers which show up on the image. The lesion location relative to the markers is identified. A corresponding external location on the subject's breast is then determined relative to reference frame. This external location may then used to target the lesion in a medical procedure.
The breast tissue should remain fixed between the imaging step and the localization or the medical procedure. If the breast tissue moves after imaging and before localization, the location relative to the reference markers will apply to different tissue than the lesion. Therefore, the breast must be immobilized.
Once the proper location of the lesion is determined, it is often necessary to insert an invasive device into the lesion as part of the medical procedure. One such procedure is to biopsy the lesion with a biopsy needle. Since the lesion material is sometimes has a higher density than surrounding breast tissue, it is not always easy to insert a biopsy device into the lesion.
Prior art devices for localization, biopsy and treatment of breast lesions provide support for the breast tissue and/or guides to insert an interventional device. However, many of these devices suffer a lack of access to the breast tissue. Sometimes it is necessary to use a scalpel to "nick" or cut the skin in order to provide biopsy or treatment access to the lesion. The prior art devices do not provide both access for a scalpel, and accurate spatial targeting simultaneously.
It is necessary to minimize the distance (the amount of tissue affected) traveled by the biopsy or interventional device. Therefore, it may also be necessary to access the lesion from either the medial or lateral side of the breast. Many prior art devices do not provide both medial and lateral access to the breast tissue.
In addition to these problems, many of the prior art devices do not pull the breast tissue away from the chest wall and access the entire breast, including most of the axilla, for localization, biopsy, treatment as well as imaging.
Currently there is a need for a breast lesion localization device which images the entire breast, guides an interventional device into the lesion accurately, and allows a Physician greater access to breast tissue.